2 051: Policy on Institutional Conflicts of Interest in Research Involving Human Subjects

amended: June 2021

Objective and scope of the policy

An institutional conflict of interest (institutional COI) is a situation in which the financial interests of an institution or an institutional manager, acting under its authority on behalf of the institution, can compromise or appear to compromise the integrity of the institution. research, education, clinical care, business transactions or other establishment activities. Institutional COIs are of great concern when financial interests create the potential for inappropriate influence on research involving human subjects.

This policy is established to ensure that the important financial interests of the University and its institutional officials do not compromise the integrity of research involving human subjects conducted at the University or under its auspices.

This policy applies to all research involving human subjects conducted at or under the auspices of the University. This policy does not eliminate the obligations of University employees with respect to the disclosure and / or management of material financial interests that are required by other University policies and procedures.

External entity

Any group, organization, or legal entity (eg, corporation, partnership, sole proprietorship, business, trust, joint venture, etc.) that is not part of the University of Nevada, Reno.

Institutional conflict of interest (institutional COI)

An Institutional Conflict of Interest (ICOI) refers to a situation in which the important financial interests of the University, or of an institutional official who has the authority to act on behalf of the University, could compromise – or appear reasonably to compromise – the integrity of the design, conduct, report, review or supervise research involving human subjects.

Research involving human subjects

For the purposes of this policy, research involving human subjects includes, without limitation, fundamental, applied and clinical research projects or programs carried out within or under the auspices of the University which require the approval of the University. ‘Institutional Review Board (IRB) of the University. Research involving exempt human subjects may be reviewed for institutional COIs on a case-by-case basis.

Establishment official

For the purposes of this policy, a facility manager is any person who i) has oversight and / or decision-making power over appointments, salaries, promotions and / or allocation of resources, such as the assignment of graduate students or space, for faculty who conduct research on human subjects at or under the auspices of the University; ii) any person who has the power to enter into an agreement with an external entity on behalf of the University for the conduct of research on human subjects; or iii) any other person so designated by the President.

Significant financial interest (individual)

For institutional managers, significant financial interests are defined in the University’s conflict of interest policy. The significant financial interests of institutional leaders will be examined from their COI statements; this policy does not require additional COI disclosures from institutional managers.

Significant financial interest (institutional)

For the purposes of this policy, an institutional financial interest is material when it meets or exceeds the applicable threshold for each specific category of financial interest, as established by the Institutional Conflicts of Interest Committee.

The following significant financial interests of the University warrant consideration of potential institutional conflicts of interest with respect to research involving non-exempt human subjects. For the purposes of this policy, the financial interests of the University include those held by the University as well as those held by another entity on behalf of the University (for example, the Nevada Research and Innovation Corporation).

1. Royalty fee: Agreements to receive milestone payments and / or royalties for the commercialization of a product or technology being researched.
2. Unlisted shares: Participation or right to the capital of any value (including options or warrants) in an unlisted company which: i) is the research sponsor; ii) owns or controls products studied, tested or evaluated; or iii) could materially benefit from the research.
3. Shares listed on the stock exchange: Share capital or right to capital (including options and warrants) in a listed company, the value of which reaches or exceeds the threshold set by the Institutional Conflicts of Interest Committee, which: i) is the research sponsor; ii) owns or controls products studied, tested or evaluated; or iii) could materially benefit from the research.
4. Gifts: Gifts (including restricted, unrestricted and in-kind) that meet or exceed the threshold set by the Institutional Conflict of Interest Committee, originating from i) a research sponsor; ii) a company which owns or controls products studied, tested or evaluated; (iii) an enterprise which could materially benefit from the research; or iv) a natural person affiliated with such a company.
5. Other: Other financial interests of the University or its institutional officials, as determined by the President.

Policy administration

The Office of the President is responsible for the administration of this policy. The president or designate must:

1. form an institutional committee on conflicts of interest (institutional CJOC) as described in the following section;
2. review and approve plans submitted by the institutional COI to manage, reduce or eliminate institutional COIs;
3. ensure that those who act on behalf of the University adhere to these policies and procedures; and
4. determine appropriate actions in response to violations of this policy.

Institutional Committee on Conflicts of Interest (Institutional CJOC)

An institutional committee on conflicts of interest (institutional CJOC) will be formed to:

1. establish significant thresholds for the financial interests of the University;
2. create procedures for compliance with this institutional policy on COIs;
3. examine potential institutional COI situations to determine if they are manageable,
4. where appropriate, recommend actions to manage, reduce or eliminate the risks so that the research can continue;
5. identify situations that are not manageable;
6. coordinate with the IRB and communicate its management decisions and plans; and
7. respond to other requests from the chair or designate.

The Institutional IOC will advise the President, who has final authority over Institutional IOC situations.

Institutional members of CJOC must have sufficient expertise, seniority and independence. The Advocate General will act as legal adviser to the institutional CJOC. The designated Conflict of Interest Officer of the University will assist the Institutional CJOC and attend all meetings. The Director of Research Integrity, or his representative, may attend meetings at his discretion. Insofar as the institutional CJOC needs clinical, scientific or other specialized knowledge to make its decisions, it will solicit this contribution from people with the appropriate expertise, either from the University or from outside the establishment.

No member of the Institutional CJOC may participate in the review of research in which that member has a significant interest with a commercial entity that could benefit from the research, except to provide the information requested by the Institutional CJOC. Members of the Institutional CJOC must disclose any financial interest that may be related to the review of the research.

The Institutional COI will meet as required to consider matters relating to the Institutional COIs and keep a record of its deliberations and actions.

Management of institutional conflicts of interest involving human research subjects

If the Institutional CJOC determines that a real or perceived institutional COI situation exists, the Institutional CJOC will recommend one of the following recommendations:

1. Research may continue, subject to an institutional COI management plan to mitigate the risks associated with institutional COIs; or
2. The institutional CI situation is unmanageable and the University must choose to either retain its significant financial interest and decline research, or eliminate significant financial interest and continue research.

A management plan can impose any condition and prescribe any action necessary to manage an institutional COI to ensure that the research is free from bias or even the appearance of bias. A management plan should take the form of a written agreement and should be signed by all parties involved.

Institutional COI management plans do not replace individual investigator COI management plans. The Institutional CJOC will work in conjunction with the designated University Conflict of Interest Officer to ensure that there is no overlap or duplication with individual COI management plans.

The final decision to proceed with University support and regulatory review will be made by the President of the University or his representative. If approved for regulatory review, research cannot be conducted without a fully signed management plan and IRB approval.

Implementation and follow-up

Each institutional COI management plan should specifically indicate who will be responsible for implementing and monitoring the plan. Compliance with the terms of the plan should be reviewed at least once a year. The Institutional COI Management Plan will remain in effect until the Institutional CJOC determines that it is no longer required.

Policy violations

Allegations of violation of this policy, including disclosure requirements and violations of an Institutional COI Management Plan, should be presented to the Institutional CJOC Chair. The CJOC Institutional President will promptly investigate the allegations. At the end of the investigation, the institution’s CJOC president reports the findings and recommendations to the university president. If warranted, administrative or disciplinary action will be determined by the President in accordance with relevant state, NSHE and university policies.